1. Field of the Invention
The present invention relates generally to medical devices, and more specifically to suturing devices and methods for applying suture to internal biological structures. The suturing devices and methods are well-suited for passing suture through the wall of a tubular biological structure from a location within the lumen or around the ostium for the purpose of closing the tubular biological structure. The suturing devices and methods are particularly well-suited for tubal sterilization.
2. Description of the Related Art
Each year, many thousands of women undergo some form of tubal sterilization in the United States and around the world. Tubal sterilization involves the blocking or removal of a segment from each of the fallopian tubes to prevent the fertilization of ovulated eggs. The various surgical methods used to accomplish tubal sterilization include: the laparoscopy method, the abdominal method, and the vaginal method.
In the laparoscopy method, one or two tiny incisions are made in the abdomen, in or near the navel. The laparoscope, a slim, lighted viewing tube, is inserted and a cauterizing instrument is passed through the laparoscope or through a second incision. The tubes are visualized so the surgeon can cauterize and seal each tube in turn.
In the abdominal method, a 3 to 4 inch incision is made just above the pubic hairline. The fallopian tubes are cut, sealed, and a section of each tube is removed. The ends of the tubes may be sealed or tied into the surrounding tissue.
In the vaginal method, the procedure is similar to the abdominal method. However, in this method the incision is made at the top of the vagina to avoid leaving a visible scar.
Unfortunately, these tubal sterilization procedures are quite invasive and involve the formation of one or more incisions. Because the incisions leave scars and can be damaging to the surrounding tissue, a need exists for an improved method for accomplishing tubal sterilization in a less invasive manner.
Hysterectomy is a common medical procedure in which the uterus is surgically removed from the body. Surgical removal of the uterus is widely accepted both by medical professionals and the public as an appropriate treatment for uterine cancer, and for various common non-cancerous uterine conditions that can produce often disabling levels of pain, discomfort, uterine bleeding, emotional distress, and related symptoms. A hysterectomy first requires cutting and tying the fallopian tubes to detach the uterus from the fallopian tubes. Accessing the fallopian tubes typically involves the formation of one or more incisions in the patient's skin as described above with respect to tubal sterilization procedures.
There are two traditional methods for removing the uterus from the body. The first method involves removing the uterus through a cut in the lower abdomen. The second method involves removing the uterus through a cut in the top of the vagina. The top of vagina is then sutured shut. Because these traditional hysterectomy methods involve the formation of one or more large incisions in the patient's abdomen or vagina in order to remove the uterus, a less invasive method is desired.
One less invasive method of hysterectomy has recently been developed and is known as laparoscopically-assisted vaginal hysterectomy (LAVH). In this procedure, a few small abdominal incisions are made which allow for the insertion of a laparoscope and specially designed instruments designed for detaching and removing the uterus. The procedure is referred to as “vaginal” because the uterus is then removed through the vagina. While this procedure has become quite popular with patients because of the shortened recovery time and reduced scarring, this method has been shown to have a higher complication rate than traditional vaginal or abdominal techniques. Therefore, an improved method for performing a hysterectomy is needed.
Vasectomy is a medical procedure in which the vas deferentia are surgically interrupted so that the sperm can no longer enter the ejaculatory ducts and fertilization cannot take place. In a conventional vasectomy, the surgeon makes one or two small incisions in the scrotum to gain access to the vas deferens. One vas deferens is isolated, drawn through the incision, and clamped at two sites close to each other. The segment between the clamps is then removed. The surgeon seals either one or two of the cut ends with sutures, clips, or cauterization using an electric needle. The vas deferens is gently placed back into the scrotum and the procedure is then repeated on the other vas deferens.
No-scalpel vasectomy (NSV) is a less invasive procedure in which the vas deferens are accessed without making any incisions in the scrotum. In this procedure, the surgeon makes only one tiny puncture in the scrotum using a special instrument. The instrument is then used to gently stretch the opening until the vas deferens can be pulled through it. The vas is then blocked using any of the same methods as conventional vasectomy.
A wide variety of other surgical procedures may involve the application of suture to biological structures, such as, for example, soft tissue approximation and the treatment of bladder or uterine prolapse. These procedures typically require the formation of one or more large incisions through the patient's skin in order to access the target site. Once the target site is accessed, the application of suture to the biological structure is often cumbersome and time consuming due to the anatomy of the biological structure or the consistency of the tissue.
Thus, there has been a long-felt need for new and improved devices and methods for applying suture to internal biological structures that are difficult to treat with existing suturing devices.